On the Banning of Drugs and Therapies

When serious problems occur in health care there is always a “knee-jerk” response by many to impose a ban and thus provide an immediate and definitive response to the issue. While such responses may be emotionally satisfying they often represent answers which are “smarter than we are” and may end up causing more harm than good.

The classic example of drug banning has been the saga of thalidomide. Thalidomide, developed in Germany in the mid-1950s, became popular on a world-wide basis as a tranquilizer and sleep inducing medication. Thalidomide initially appeared to be safe. The fact that it was a teratogen (capable of causing birth defects) associated with maldevelopment of fetal extremities was not immediately evident. At the United States Food and Drug Agency in November of 1960 the official in charge of the new drug application was FDA staffer Francis Kelsey, M.D. who delayed the application to check out concerns about possible side-effects not related to teratogenicity. The disclosure, in 1961, that this drug was actually the etiology of dramatic fetal skeletal deformities in about 8,000 infants burst like a thunderclap on the global medical landscape. The full identification of this serious side-effect in the United States, and the communication of this to the medical community was, in large part, due to the work of Helen B. Taussig, M.D. at Johns Hopkins Hospital. The “knee-jerk” reaction was to ban thalidomide in many countries. Fortunately, at that time thalidomide had not been distributed in the United States.

Despite its well-deserved notoriety thalidomide has been found, since its banning, to have a number of important medical uses including the treatment of cancer as well as preventing the loss of appetite and weight associated with AIDs and in treating tuberculosis and leprosy. With a better understanding of its risks among informed patients thalidomide has been rehabilitated.

Those individuals afflicted with the cruel disability of a lifetime of intractable pain related to the introduction of neurotoxic substances into the subarachnoid space and the subsequent creation of adhesive arachnoiditis have lobbied to ban the use of such substances. This has been particularly true for the contrast agent iophendylate used for myelography throughout (450,000 cases per year in the United States alone) the world from the 1940s to the 1980s.

Iophendylate, as Pantopaque® or Myodil®, was originally introduced as a hyperbaric contrast agent intended to be used, in small amounts, to localize tumors in the spinal canal. How it then became used for full-column routine myelography to diagnose disc herniations is a complete medical mystery. Despite its high level of toxicity iophendylate continued to be of medical value for the localization of spinal tumors where the risk: benefit ratio was in the patient’s favor, particularly under circumstances where CT or MRI were not available.

If “banning” ever made sense (which it doesn’t) iophendylate should have been first on a long list. As it turns out it was never banned (or even proscribed or prohibited). The sadness is that its toxicity has never yet been officially recognized by any medical or governmental agency. This toxic agent only “fell into disuse.” Because of this phenomenon its toxicity and real patient risk factors have never been popularized precluding the possibility of informed consent being present. This continuing ignorance associated with continuing lack of disclosure of risk is a primary reason why other neurotoxic substances continue to be responsible in continuing to produce adhesive arachnoiditis.

Summary:What lessons have we learned from history? On August 7, 1962 Dr. Francis Kelsey was awarded the Distinguished Civil Service Award presented by John F. Kennedy. It is clear today that Dr. Kelsey’s initial concerns about thalidomide at the time were not related to its teratogenicity. The Kelsey episode did a great deal to increase nit-picking at the FDA regarding new drug applications. FDA super caution has had a serious effect on new drug applications leading many to suggest that the FDA really does not understand its mandate and that significant agency reform is needed. These voices are increasing in number.

Unfortunately we have not yet learned that the the banning of therapeutic agents/drugs is not warranted. The banning of the non-steroidal drug Vioxx is a more recent example of this. What is warranted is the clear identification of known risk and the communication of this to patients so that they can be provided with accurate information and thus allow for true informed consent to be present. It is informed consent which is the safeguard not the banning. This safeguard is, however, only meaningful when there are health care consumers placed in the driver’s seat who have the motivation and means to seek out these truths and are also capable of effectively using this information.

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